Rabies HumanPhase 3rabiesNCT06177249
To Evaluate the Immunogenicity and Safety of Two Different Immunization Schedules of Rabies Vaccine (Vero Cell)
A Phase 3 study testing Experimental vaccine in people with Rabies Human, run by Hualan Biological Bacterin Co. Ltd. at 1 site in China.
Trial summary
To evaluate the safety and immunogenicity of lyophilized human rabies vaccine (Vero cell) developed by Hualan Biological in healthy people aged 9 to 65 years with two different immunization schedules. Read more about this study
- Who is it for?
- Ages 9 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies Human
- What is being tested?
- Experimental vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,956 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2015to 1 May 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 9 to 65 years old healthy residents;
- volunteered for the experiment and signed informed consent;
- the subjects or their guardians can comply with the requirements of the clinical trial protocol;
- have not received rabies vaccination at any time;
- nearly six months has not been mammals bite, scratch;
- not participating in clinical trials of other drugs;
- No use of human immunoglobulin or other products in the past six months.
Who cannot join
- First needle exclusion:
- have allergies, convulsions, seizures, mental and nervous system, such as history, or family history of epilepsy;
- Allergic to the main ingredient of the investigational vaccine;
- known to people with poor immune function damage or the tumor, spleen;
- Axillary temperature >38.0℃ within 7 days due to acute febrile illness;
- Patients with axillary body temperature > 37.0℃;
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- Severe chronic diseases such as congenital malformation, developmental disorder or severe cardiovascular disease, diabetes mellitus, hypertension that cannot be stabilized by drugs, liver and kidney diseases, and malignant tumors;
- patients with acute and chronic infectious diseases, active infections, severe asthma, infectious skin diseases;
- pregnant and lactating women; Any circumstances that the investigator believes may affect the assessment of the trial.
- Subsequent needle exclusions:
- any serious adverse event causally related to vaccination;
- new findings that meet the "first dose exclusion criteria";
- the researchers think that may affect test evaluation of any situation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation With Rabies Vaccine (Vero Cell) of Two Different Immune Procedure in the Healthy Crowd the Immunogenicity and Safety of Randomized, Blinded, Similar Vaccine Against Ⅲ Phase of Clinical Trials
To evaluate the safety and immunogenicity of lyophilized human rabies vaccine (Vero cell) developed by Hualan Biological in healthy people aged 9 to 65 years with two different immunization schedules.
Read the detailed description
The trial to assess the rabies vaccine (Vero cells) in healthy group of 9 ~ 65 years old after inoculation, the first dose after 14 days and 14 days after inoculation 5 agent group turn antibody positive rate of bad effect on 5 agent in the control group; The safety profile, seroconversion rate, and geometric mean concentration of the four-dose vaccine were noninferior to those of the five-dose regimen at 14 days after the first dose. More people aged 9-65 in the first agent free after 7 days, 14 days and 14 days after inoculation, 5 patients and 5 doses in the control group, four patients and 5 doses group antibody positive rate, GMC and GMC growth multiples have differences. To evaluate whether the seroconversion rate of subjects in the 4-dose experimental group reached 100% 14 days after the whole course of vaccination.
- Conditions
- Rabies Human
- Being tested
- Control vaccine, Experimental vaccine
- Keywords
- Antibody Titer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control vaccineBiological
A group of 652 subjects were vaccinated with the control vaccine at 0, 3, 7, 14 and 28 days (5 doses in total). Blood samples were collected from the subjects at 0, 7/14 and 35/42 days for antibody detection.
Experimental vaccineBiological
A total of 652 subjects received 5 doses of the vaccine at 0, 3, 7, 14 and 28 days. Blood samples were collected on 0, 7/14 and 35/42 days for antibody detection.
| Study group | Role | What they receive |
|---|---|---|
| Experimental vaccines and vaccine | Active comparator | A total of 1956 subjects were randomly divided into three groups at a ratio of 1:1:1, 652 subjects in each group were vaccinated with the test vaccine or the control vaccine on a schedule of 0, 3, 7, 14, 28 days (a total of 5 doses). Blood samples were collected from the subjects for antibody detection on 0, 7/14, 35/42 days, respectively. Receives: Biological: Control vaccine; Biological: Experimental vaccine |
| experimental vaccines | Active comparator | An additional group of 652 people received the trial vaccine in a 0 -, 7 -, and 21-day schedule (two first doses for a total of four doses). Blood samples were collected at 0, 7/14 and 35/42 days for antibody detection, and all subjects were systematically observed for safety. Receives: Biological: Experimental vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
1956 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention
Tenderness, pruritus, induration, redness, swelling and its degree of size and disturbance of body activity at the inoculation site
Measured: Every needle 30 days after vaccination
1956 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention
Tenderness, pruritus, induration, redness, swelling and its degree of size and disturbance of body activity at the inoculation site
Measured: Vaccinations 31 days to 180 days
1956 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.
Fever, allergy, headache, fatigue, nausea and vomiting, diarrhea, muscle pain, arthralgia and so on were observed
Measured: Every needle 30 days after vaccination
1956 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.
Fever, allergy, headache, fatigue, nausea and vomiting, diarrhea, muscle pain, arthralgia and so on were observed
Measured: Vaccinations 31 days to 180 days
Secondary outcomes (2)
The immunogenicity was tested by immunofluorescence staining
The rabies virus antibody was detected by immunofluorescence focus method. The positive rate was defined as the serum antibody concentration ≥0.5IU/ml
Measured: 5 agent group gathering subjects were 0, 7, 14, 42 days of blood samples
The immunogenicity was tested by immunofluorescence staining
The rabies virus antibody was detected by immunofluorescence focus method. The positive rate was defined as the serum antibody concentration ≥0.5IU/ml
Measured: Blood samples were collected on day 0, 7, 14 and 35 in the 4-dose group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start15 Mar 2015
- Primary completion16 Dec 2015
- Study completion1 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rabies HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Lyophilized rabies vaccine for human use (Vero cell) and control vaccine
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,956 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hualan Biological Bacterin Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Henan Center for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177249
- Sponsor's protocol ID
- 2014L00266
- Acronym
- rabies
- Status last verified
- Mar 2015
- First submitted
- 7 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation With Rabies Vaccine (Vero Cell) of Two Different Immune Procedure in the Healthy Crowd the Immunogenicity and Safety of Randomized, Blinded, Similar Vaccine Against Ⅲ Phase of Clinical Trials
- ClinicalTrials.gov ID
- NCT06177249
- Acronym / sponsor ID
- rabies / 2014L00266
- Conditions
- Rabies Human
- Keywords
- Antibody Titer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,956 participants (actual)
- Lead sponsor
- Hualan Biological Bacterin Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Henan Center for Disease Control and Prevention
- Study start
- 15 Mar 2015 (actual)
- Primary completion
- 16 Dec 2015 (actual)
- Study completion
- 1 May 2016 (actual)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and immunogenicity of lyophilized human rabies vaccine (Vero cell) developed by Hualan Biological in healthy people aged 9 to 65 years with two different immunization schedules.
Detailed description
The trial to assess the rabies vaccine (Vero cells) in healthy group of 9 ~ 65 years old after inoculation, the first dose after 14 days and 14 days after inoculation 5 agent group turn antibody positive rate of bad effect on 5 agent in the control group; The safety profile, seroconversion rate, and geometric mean concentration of the four-dose vaccine were noninferior to those of the five-dose regimen at 14 days after the first dose. More people aged 9-65 in the first agent free after 7 days, 14 days and 14 days after inoculation, 5 patients and 5 doses in the control group, four patients and 5 doses group antibody positive rate, GMC and GMC growth multiples have differences. To evaluate whether the seroconversion rate of subjects in the 4-dose experimental group reached 100% 14 days after the whole course of vaccination.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Lyophilized rabies vaccine for human use (Vero cell) and control vaccine
| Arm | Type | Receives |
|---|---|---|
| Experimental vaccines and vaccine | Active comparator | Biological: Control vaccine, Biological: Experimental vaccineA total of 1956 subjects were randomly divided into three groups at a ratio of 1:1:1, 652 subjects in each group were vaccinated with the test vaccine or the control vaccine on a schedule of 0, 3, 7, 14, 28 days (a total of 5 doses). Blood samples were collected from the subjects for antibody detection on 0, 7/14, 35/42 days, respectively. |
| experimental vaccines | Active comparator | Biological: Experimental vaccineAn additional group of 652 people received the trial vaccine in a 0 -, 7 -, and 21-day schedule (two first doses for a total of four doses). Blood samples were collected at 0, 7/14 and 35/42 days for antibody detection, and all subjects were systematically observed for safety. |
Who may qualify
- Ages
- 9 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 9 to 65 years old healthy residents;
- volunteered for the experiment and signed informed consent;
- the subjects or their guardians can comply with the requirements of the clinical trial protocol;
- have not received rabies vaccination at any time;
- nearly six months has not been mammals bite, scratch;
Key exclusion criteria (13 listed)
- have allergies, convulsions, seizures, mental and nervous system, such as history, or family history of epilepsy;
- Allergic to the main ingredient of the investigational vaccine;
- known to people with poor immune function damage or the tumor, spleen;
- Axillary temperature >38.0℃ within 7 days due to acute febrile illness;
- Patients with axillary body temperature > 37.0℃;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control vaccineA group of 652 subjects were vaccinated with the control vaccine at 0, 3, 7, 14 and 28 days (5 doses in total). Blood samples were collected from the subjects at 0, 7/14 and 35/42 days for antibody detection. | Biological | Experimental vaccines and vaccine |
| Experimental vaccineA total of 652 subjects received 5 doses of the vaccine at 0, 3, 7, 14 and 28 days. Blood samples were collected on 0, 7/14 and 35/42 days for antibody detection. | Biological | Experimental vaccines and vaccine, experimental vaccines |
Primary outcome
1956 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention
Time frame: Every needle 30 days after vaccination
Tenderness, pruritus, induration, redness, swelling and its degree of size and disturbance of body activity at the inoculation site
1956 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention
Time frame: Vaccinations 31 days to 180 days
Tenderness, pruritus, induration, redness, swelling and its degree of size and disturbance of body activity at the inoculation site
1956 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.
Time frame: Every needle 30 days after vaccination
Fever, allergy, headache, fatigue, nausea and vomiting, diarrhea, muscle pain, arthralgia and so on were observed
1956 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.
Time frame: Vaccinations 31 days to 180 days
Fever, allergy, headache, fatigue, nausea and vomiting, diarrhea, muscle pain, arthralgia and so on were observed
2 secondary outcomes
The immunogenicity was tested by immunofluorescence staining
Time frame: 5 agent group gathering subjects were 0, 7, 14, 42 days of blood samples
The immunogenicity was tested by immunofluorescence staining
Time frame: Blood samples were collected on day 0, 7, 14 and 35 in the 4-dose group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental vaccine in people with Rabies Human, run by Hualan Biological Bacterin Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1956 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention (time frame: Every needle 30 days after vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.